RECRUITING

Benchmark Evidence Led by Latin America: Trial of Intracranial Pressure - Pediatrics

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Narrative: Worldwide, traumatic brain injury (TBI) is a leading cause of death and disability among children and adolescents. The Investigators aim to test whether pediatric TBI treatment guided by invasive intracranial pressure monitoring produces better patient outcomes than care guided by a protocol without invasive monitoring. Study findings will inform clinical practice in treating pediatric severe TBI globally. Focused didactic and experience-based learning opportunities will increase the research capacity of pediatric intensivists in Latin America.

Official Title

Pediatric Severe Traumatic Brain Injury in Latin America - A Randomized Trial Comparing Two Management Protocols

Quick Facts

Study Start:2023-03-22
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05566431

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:1 Year to 12 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. 1. Provision of signed and dated informed consent form by the parent(s) or guardian(s)
  2. 2. Non-penetrating TBI
  3. 3. Admission to study hospital within 24 hours of injury
  4. 4. Total GCS score ≤ 8 on admission or within first 48 hours after injury (measured using pediatric GCS 1 for children \< 2 years old and standard GCS for older children)
  5. 5. Age 1 through 12 years
  6. 6. Able to randomize:
  7. * Within 24 hours of injury (for patients with GCS ≤ 8 on admission) OR
  8. * Within 24 hours of deterioration (for patients deteriorating to GCS ≤ 8 within 48 hours of injury)
  1. 1. Motor GCS score of 6
  2. 2. GCS of 3 with bilaterally fixed and dilated pupils
  3. 3. Injury thought to be intentionally inflicted by a family member or caregiver.

Contacts and Locations

Study Contact

Randall M Chesnut, MD
CONTACT
2067449322
chesnutr@uw.edu
Kelley Chaddock, BA
CONTACT
2067449322
chaddk@uw.edu

Principal Investigator

Randall Chesnut, MD
PRINCIPAL_INVESTIGATOR
University of Washington

Study Locations (Sites)

University of Washington, Harborview Medical Center
Seattle, Washington, 98104
United States

Collaborators and Investigators

Sponsor: University of Washington

  • Randall Chesnut, MD, PRINCIPAL_INVESTIGATOR, University of Washington

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-22
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2023-03-22
Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

  • sTBI
  • ICP monitoring
  • randomized controlled trial
  • TBI management
  • Latin America
  • pediatric
  • Phase III

Additional Relevant MeSH Terms

  • Severe Traumatic Brain Injury